(61 days)
Not Found
Not Found
No
The summary describes a traditional surgical suture and contains no mention of AI, ML, or related concepts.
No.
The device is an absorbable suture, which is used for wound closure and tissue approximation, not for therapy in the traditional sense.
No
This device is a surgical suture used for approximation and/or ligation of soft tissues, not for diagnosing medical conditions.
No
The device is a physical suture made of polydioxanone, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is a surgical suture used for soft tissue approximation and/or ligation. This is a physical device used in vivo (within the body) during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures U.S.P. are indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDO is not indicated for use in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are useful where an absorbable suture with extended wound support (up to six weeks) is desirable.
Product codes
NEW
Device Description
Monofilament Synthetic Absorbable Sutures. PDO (Polydioxanone) U.S.P. manufactured by ARC Medical Supplies (Beijing) Co., Ltd. are equivilent to MONO-DOX synthetic absorbable polydioxanone surgical sutures manufactured by CP Medical.
The PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures, U.S.P. manufactured by ARC Medical and CP Medical are monofilament suture composed of a Poly(p-dioxanone) acid, un-dyed or dyed with D&C Violet No. 2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, pediatric cardiovascular tissue, ophthalmic
Indicated Patient Age Range
pediatric
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of suture diameter, suture length, knot pull tensile strength, needle attachment strength and absorption rate according to methods outlined in U.S.P. XXIII demonstrates that ARC Medical PDO (Polydioxanone) Monofilament Synthetic Absorbable sutures meet or exceed U.S.P. specifications and are equivalent in terms of the above parameters to Synthetic Absorbable polydioxanone surgical sutures manufactured by CP Medical.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
Kozz b.i.^{24}_{6}
ARC Medical Supplies(Beijing) Co., Ltd.
OCT 0 9 2002
#66 Qian Ban Bi Jie, Xizhirnen Nei, Beijing CHINA 100035 Tel: 8610-6617 8581 Fax: 8610-66113481 Email: arcmedic@public.bta.net.cn
Page 1 of 2
510(k) SUMMARY
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
| Applicant | ARC Medical Supplies (Beijing) Co., Ltd.
#66 Quian Ban Bi Jie, Xizhimen Nei
Beijing, China 100035
Telephone: 8610 6617 8581
Fax: 8610 6611 3481 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Mr. Charles F. Andrews
C.F. Andrews & Associates
1591 S. Moorland Road, Suite 104
New Berlin, WI 53151
Telephone: (414) 416-9119
Fax: (414) 389-1650 |
| Date | August 7, 2002 |
| Name of Device | |
| Proprietary Name: | PDO (Polydioxanone) Monofilament
Synthetic Absorbable Suture U.S.P. |
| Common or Usual Name: | Polydioxanone Monofilament
Synthetic Absorbable Suture U.S.P. |
| Classification Name: | Suture, Absorbable, Synthetic, Polydioxanone |
1
Korticki
ARC Medical Supplies(Beijing) Co., Ltd.
#66 Qian Ban Bi Jie, Xizhimen Nei, Beijing CHINA 100035 Tel: 8610-6617 8581 Fax: 8610-66113481 Email: arcmedic@public.bta.net.cn
Page 2 of 2
510(k) SUMMARY - continued
Monofilament Synthetic Absorbable Sutures. PDO (Polydioxanone) U.S.P. manufactured by ARC Medical Supplies (Beijing) Co., Ltd. are equivilent to MONO-DOX synthetic absorbable polydioxanone surgical sutures manufactured by CP Medical.
The PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures, U.S.P. manufactured by ARC Medical and CP Medical are monofilament suture composed of a Poly(p-dioxanone) acid, un-dyed or dyed with D&C Violet No. 2.
PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDO is not indicated for use in adult cardiovascular tissue, microsurgery and neural These sutures are useful where an absorbable suture with extended wound tissue. support (up to six weeks) is desirable.
Testing of suture diameter, suture length, knot pull tensile strength, needle attachment strength and absorption rate according to methods outlined in U.S.P. XXIII demonstrates that ARC Medical PDO (Polydioxanone) Monofilament Synthetic Absorbable sutures meet or exceed U.S.P. specifications and are equivalent in terms of the above parameters to Synthetic Absorbable polydioxanone surgical sutures manufactured by CP Medical.
K
Richard Kuo, Chairman
P-L-Q
I Date
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ARC Medical Supplies (Beijing) Co., Ltd. c/o Mr. Charles F. Andrews President C.F. Andrews & Associates 1591 S. Moorland Road, Suite 104 New Berlin, Wisconsin 53151
OCT 0 9 2002
Re: K022666
Trade/Device Name: PDO (Polydioxanone) Monofilament Synthetic
Absorbable Suture Regulation Number: 21 CFR 878.4840
Regulation Name: Suture, surgical, absorbable, polydioxanone Regulatory Class: Class II Product Code: NEW Dated: August 29, 2002 Received: August 30, 2002
Dear Mr. Andrews:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Charles F. Andrews
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Styt Rlvelu
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO2266
510(k) Number : K022666
Device Name:
PDO (Polydioxanone) Monofilament Synthetic Absorbable Suture U.S.P.
Indications for Use: PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures U.S.P. are indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDO is not indicated for use in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are useful where an absorbable suture with extended wound support (up to six weeks) is desirable.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styp Purcle
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K022666